Flo’s science team conducted two three-month, unblinded, two-armed, remote, pilot randomized controlled trials (RCTs) on a sample of women in the United States comparing app use with non-use.1
Trial 1 included 321 women who tracked their cycles and trial 2 included 117 women who, in addition to tracking their cycles, are affected by premenstrual syndrome (PMS) or premenstrual dysphoric disorder (PMDD).
In trial 1, the team assessed primary outcomes of menstrual health literacy and self-reported menstrual health and health and well-being scores. Secondary outcomes were the effect of app use on overall feelings of health management, communication about health, menstrual cycle stigma, fear of unplanned pregnancies, quality of life, and body image.
In trial 2, primary outcomes were PMS and PMDD-related health literacy and symptom burden. Secondary outcomes were quality of life, productivity at work, and absenteeism from work or education.
The results are published in JMIR mHealth and uHealth.
This trial was conducted in collaboration with Sarah Hill, PhD, a professor in the department of psychology at Texas Christian University, Texas, US.
Menstrual health literacy was assessed using a 12-point questionnaire, including questions around typical bleeding length, how menstrual cycle length is calculated, and pain relief for menstrual symptoms.
There was a greater improvement in menstrual health literacy in the intervention group compared with the control group with an increase in the mean health literacy score by 1.1 (p < 0.001) in the intervention group and 0.52 (p = 0.003) in the control group.
Mean self-reported menstrual health awareness scores — as measured using seven questions selected from the 33-item Health Literacy Instrument for Adults, modified for this study to be relevant to cycle tracking — increased by 3.97 (p < 0.001) in the intervention group compared with 1.85 (p < 0.001) in the control group.
Finally, self-reported general health and well-being were assessed using 14 questions, selected from domain 2 of the World Health Organization Quality of Life brief survey and designed internally by Flo, using input from Flo’s medical advisors. Scores increased by 3.44 (p < 0.001) in the intervention group and by 0.76 (p = 0.14) in the control group.
There were improvements in many, but not all, of the secondary outcome measures.
Sole improvements in the intervention group scores were observed for:
The score for feelings of control and management of health improved by 1.00 (p < 0.001) in the intervention group and by 0.45 points (p = 0.01) in the control group.
There were no improvements in body image scores in either group. “Body image is a complex topic and may need a more targeted approach than we provided in this study. While the Flo app does have some content that addresses this, a longer period of app use may be needed to see a difference,” Adam Cunningham, PhD, lead research scientist at Flo and first author of the study, commented on the findings.
In a recent scoping review, the Data and Digital Health unit at the World Health Organization explored the role of digital health technologies (DHTs), including mHealth apps, in female health, empowerment, and gender equality.
The authors found positive effects of DHTs.
“The utilization of digital technologies directly impacted women’s empowerment and gender equality either by serving as a skills-acquisition system or a health education portal/health literacy platform,” they write in the review.
As the results of this trial demonstrate, access to Flo increased a number of female health outcomes, contributing to health, well-being, and equality.
The second trial was conducted in collaboration with Dr. Jennifer Payne, a professor of psychiatry and neurobehavioral sciences at the University of Virginia, Virginia, US, and Liisa Hantsoo, PhD, an assistant professor of psychiatry and behavioral sciences at Johns Hopkins University, Maryland, US.
PMS/PMDD-related health literacy was assessed using questions around incidence, symptoms, and methods that can be used to help manage symptoms — developed by Flo with input from Flo’s medical advisors. Mean PMS/PMDD health literacy scores increased by 1.2 (p < 0.001) in the intervention group and by 0.64 (p = 0.02) in the control group.
PMS/PMDD symptom burden was assessed using the Premenstrual Symptom Screening Tool. Scores decreased by 7.08 (p < 0.001) in the intervention group and by 5.24 (p < 0.001) in the control group.
Absenteeism due to PMS or PMDD symptoms was assessed by asking participants how many days of absence they had taken from work, university, or school in the past three months.
The mean number of absent days decreased by 1.67 (p = 0.04) in the intervention group, while there was no difference in the control group.
There were no changes in the work productivity or quality of life scores in either group, which — as with body image in the first trial — may be due to a number of factors, including the complex nature of these measures, the time frame of the study, and the insufficiently specific health information around these topics.
Flo’s RCT highlights the opportunities that digital health interventions provide in improving PMS and PMDD health literacy and reducing symptom burden and absenteeism.
Given the high prevalence of PMS and PMDD, the positive impact on patients and their health care professionals is likely significant.
Although participants in the control group were asked not to use the Flo app, it wasn’t possible in this study to guarantee that they, in fact, didn’t. Thus, it’s feasible that improvements in the control group were due to some participants using the Flo app.
Enrollment in the study may also have prompted the participants in the control group to seek health information elsewhere, leading to improvements in health literacy and other scores in this group.
Longer intervention times may have resulted in great effect sizes and additional significant outcomes in the secondary measures. Although three-month interventions are common practice in health app testing, it’s possible that outcomes such as body image, productivity at work, and quality of life require longer time frames.
While participant numbers were adequate for a pilot RCT, additional studies are now ongoing with more volunteers to sufficiently power full RCTs.
Finally, this pilot RCT study included women in the United States who were English speakers, making it challenging to generalize the findings to other populations. Future work should include participants from diverse backgrounds to produce robust results that apply to women and people who menstruate across the globe.
“Medical accuracy and efficacy are at the root of Flo. We work with an international team of 120+ doctors, health experts, and scientific researchers to ensure that everything at Flo — from the content to app features — is medically accurate and scientifically proven to be effective for our users,” Liudmila Zhaunova, PhD, director of science at Flo, commented.
“This study has given us further confidence and evidence that using Flo can lead to improved health outcomes,” she continued.
These trial results reinforce the role that evidence-based digital tools can play in supporting female health, particularly when it comes to improving health literacy and symptom management in PMS and PMDD.
To support health care professionals in implementing this evidence, Flo offers a complimentary OB-GYN Co-Care Pack, designed to empower patients with trustworthy, expert-reviewed education and tracking tools.
Request your Co-Care Pack to access materials tailored for your clinic and your patients.